UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For
the month of July 2026
Commission
File Number: 001-43353
CLINUVEL
PHARMACEUTICALS LIMITED
Level
22, 535 Bourke Street
Melbourne,
VIC 3000
Australia
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form
20-F ☒ Form 40-F ☐
INFORMATION
CONTAINED IN THIS FORM 6-K REPORT
On
July 21, 2026, Clinuvel Pharmaceuticals Limited filed with the Australian Securities Exchange an announcement captioned “CLINUVEL’s
ADS commences trading on Nasdaq”, a copy of which announcement is attached to this Form 6-K as Exhibit 99.1.
Exhibits
| Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Press release dated July 21, 2026 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
| |
CLINUVEL
PHARMACEUTICALS LIMITED |
| |
|
|
Date: July 21, 2026
|
By: |
/s/
Philippe Wolgen |
| |
Name:
|
Philippe
Wolgen |
| |
Title: |
Managing
Director and Chief Executive Officer |
Exhibit
99.1

CLINUVEL’s
ADS commences trading on Nasdaq
Ticker
symbol CUVL
Melbourne
/ New York – 21 July 2026 – CLINUVEL PHARMACEUTICALS LTD (ASX: CUV | Nasdaq: CUVL) today confirmed that its American
Depositary Share (ADS) commenced trading on the Nasdaq Stock Market (Nasdaq) on 20 July (New York time) under the ticker symbol CUVL.
This completes the uplift of CLINUVEL’s previous American Depositary Receipt (ADR: CLVLY) from Level I to Level II. Holders of
the previous CLVLY should contact their broker regarding any questions on their holdings.
–
END –
| ASX Announcement | PAGE 1 OF 2 |
About
CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL
is a global biopharmaceutical company focused on developing and delivering innovative therapies for patients with genetic, metabolic,
and dermatological disorders. The Company’s portfolio is centred around melanocortin peptides, with programs advancing in photomedicine
and vitiligo. CLINUVEL is listed on the Australian Securities Exchange (ASX: CUV) and the Nasdaq Stock Market (Nasdaq: CUVL).
CLINUVEL’s
lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Canada, Israel, and Australia
as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult
patients with erythropoietic protoporphyria (EPP). For further information, visit www.clinuvel.com.
Authorised
for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD.
Head
of Investor Relations
Mr
Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD
Investor
Enquiries
https://www.clinuvel.com/investors/contact-us
Forward-Looking
Statements
This
release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. All statements
other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements
in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,”
“could,” “estimate,” “expect,” “foresee,” “intend,” “likely,”
“may,” “objective,” “potential,” “plan,” “predict,” “project,”
“seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements
reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons.
Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ
significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to
such differences include but are not limited to risks relating to: our ability to develop and commercialise pharmaceutical products;
pandemics, epidemics, public health emergencies, geopolitical conflicts, trade restrictions, natural disasters and other disruptions
affecting global supply chains, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products;
competition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®,
NEURACTHEL® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and
efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for
innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability
claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China,
Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions
as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company
may incur unexpected delays in the outsourced manufacturing of SCENESSE®, CYACÊLLE, PRÉNUMBRA®,
NEURACTHEL® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve
its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system
(i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding
the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions
by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain
or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and
related industries; potential changes to tax liabilities or legislation; environmental risks including the risk factors described in
the Company’s Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission, together with the
Company’s announcements lodged with the Australian Securities Exchange. Forward-looking statements speak only as of the date on
which they are made, and the Company undertakes no obligation except as required by applicable law, the rules of the Australian Securities
Exchange, the U.S. Securities and Exchange Commission, Nasdaq, or other applicable regulatory requirements, to update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts
and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.
Contact:
Tel:
+61 3 9660 4900
Fax:
+61 3 9660 4909
Email:
mail@clinuvel.com
Australia
(Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia

| ASX Announcement | PAGE 2 OF 2 |